• Potential pathogenicity, toxicity and allergenicity to humans during culture, formulation and use of the microorganism must be considered, as must residues in plant products and foods.

• The risk of negative effects in the environment, including agricultural production systems. The risk of pathogenicity or toxicity to organisms other than humans needs to be considered. Information is also required on the organism’s persistence and spread to surrounding areas.

Safety is interconnected with legislation:
A multitude of different legal systems, both national legislation and international conventions and agreements as well as policies, influence the possibilities to domesticate and use beneficial microorganisms. For some applications - e.g. biological control - current legislation prescribe thorough documentation and authorisation before marketing. The use of genetically modified microorganisms are governed by specific legislation, but DOM focus on the big but largely unexplored potential of naturally occurring microorganisms.

Central activities

A new framework to determine the safety profile of microbes:
A new strategy for initial determination of the safety profile of new microbial strains has been evaluated. It encompasses collection and evaluation of scientific literature and other information, determination of antibiotic resistance pattern, temperature range for growth, and in vitro testing of production of toxic substances and potential pathogenicity. This system can reveal whether any particular precautions are needed for handling and using a particular organism, and hence whether the strain is suitable for product development.

Biological assays to screen for production of toxic substances:
The phagotrophic (particle feeding) unicellular ciliate Tetrahymena pyriformis is used as a biosensor for detection of toxic substances produced by microorganisms. In particular, we develop new methodology capable of detection of biologically active microbial metabolites in complex crude extracts and homogenates of microorganisms. For this purpose, we use high through put-systems for rapid determination of effects of test substances on Tetrahymena growth kinetics.

Genetic markers for studies of spread and persistence of organisms:
Genetic markers were developed for specific detection and quantification of the biocontrol bacterium Pseudomonas brassicacearum MA250. The markers were successfully evaluated in a greenhouse experiment with winter wheat inoculated with MA250. Next, they are used to study the persistence and spread of the bacterium in field experiments. Additionally, we have adapted the marker methodology for quantification of MA250 in aerosols.

Examining the legal structures which regulate microorganisms:
Regulatory conditions for beneficial microbes differ markedly depending on the intended application, the country and the type of organism. In order to gather and present recent developments and stimulate a critical and productive discussion, DOM arranged the combined course and symposium “Microbes and the Law - Setting the Limits for Practical Use”  in October 2008. We also perform a critical examination of the current completely different safety evaluations of biocontrol agents based on micro- as opposed to macroorganisms.    

Personnel

Prof. Ingvar Sundh is leading the work on safety. Main contributors are Dr. Annika Nilsson (test systems for human toxicity and pathogenicity) and postgraduate student Anna-Ida Johnsson and Ass. Prof. Petter Melin (the SCAR-marker project).